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卫生密封件行业术语
发布日期:2021-04-14
Abrasion - The process of scraping or wearing away material.
(磨损-刮擦或磨损材料的过程。)
 
CGMP - Current Good Manufacturing Practices are published by the FDA and are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use.
CGMP-目前的良好生产实践,由FDA发布,供制药、医疗设备和食品制造商用来生产和测试人们使用的产品。)
 
CIP - Clean-in-place, equipment and techniques that allow process equipment to be cleaned without dismantling or manual cleaning.
CIP-现场清洁,设备和技术,允许清洁工艺设备,而无需拆卸或手动清洁。)
 
COP - Clean-out-of-place, a method of cleaning equipment items by removing them from their operational area and taking them to a designated cleaning station for cleaning.
COP-非现场清洁,一种将设备物品从操作区域移走并带到指定的清洁站进行清洁的方法。)
 
Elastomer - a natural or synthetic polymer having elastic properties, i.e., rubber.
(弹性体-一种具有弹性性能的天然或合成聚合物,比如橡胶。)
 
Gasket - a shaped piece or ring of rubber, or other material, sealing the junction between two surfaces in an engine or other device.
(垫圈-一种成型的部件或者圆环,用橡胶或其他材料制成,密封发动机或其他装置中的两个表面之间的结合处。)
 
I.D. -  the inner dimension of a gasket
I.D.-一个垫圈的内部尺寸)
 
O.D. -  the outer dimension of a gasket
O.D.-一个垫圈的外部尺寸)
 
Sanitary Fitting - used to join two or more pipes or tubes together or to some other component.
(卫生配件-用于连接两个或多个管道在一起或到一些其他部件。)
 
Seal - a device designed to prevent or control the movement of fluid from one chamber to another.
密封-一种旨在防止或控制流体从一个房间向另一个房间移动的装置。
 
SIP - Steam-in-place, heating or chemical sterilization of process equipment.
(使用现场蒸汽、加热或化学方法对工艺设备灭菌。)
 
Sterilization - A term referring to any process that removes or kills all forms of life present on a surface, contained in a fluid, in medication, or in a  compound.
(灭菌—是指一个过程,该过程用来去除或杀死液体、药物或化合物表面或内部的所有生命形式。)
 
Validation - As it relates to the spray equipment, the process of validation involves the qualification of the manufacturing process to ensure that it is stable and reliable so that the corresponding manufactured drugs meet specifications. Once an equipment or a process is validated, a new validation is required if any change is made.
(验证—由于它与喷雾设备有关,验证过程涉及到制造过程的鉴定,以确保其稳定可靠,使相应的制造药品符合规范。一旦设备或工艺得到验证,如果进行了任何更改,则需要进行新的验证。)
 
WFI - Water for injection (RO-reverse osmosis, DI-deionized water).
WFI-注射用水(反渗透、DI去离子水)
 
 
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